[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"psoriatic-arthritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:psoriatic-arthritis":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,55,0,25,[9,46,67,90,116,139,173,201,223,244,273,296,320,344,403,434,468,492,514,538,562,595,622,642,661],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100567691","phase-3-a-study-of-zasocitinib-in-adults-with-psoriatic-arthritis-who-have-not-taken-biologic-medicines-100567691",false,"NCT06671483","A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines","A Multi-Center, Randomized, Double-Blind, Placebo- and Active-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-Modifying Antirheumatic Drugs (LATITUDE-PsA-3001)","Inclusion Criteria:\n\nAge:\n\n1. The participant is aged 18 years or older at the time of signing the informed consent form (ICF). In South Korea, the age requirement for adult participants is \\>=19 years of age.\n\n   Disease Characteristics:\n2. The participant has a diagnosis of PsA.\n3. The participant must have signs and symptoms of PsA for at least 3 months prior to screening.\n4. The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).\n5. The participant has active arthritis as shown by a minimum of \\>=3 tender joints in TJC68 and \\>=3 swollen joints in SJC66 at the screening and baseline (Day 1) visits.\n6. The participant has at least 1 active lesion of plaque PsO \\>=2 cm in diameter, or any nail or nail bed changes characteristic of PsO.\n\n   Medications for PsA:\n7. The participant has had at least one of the following:\n\n   1. Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (not applicable in the European Union \\[EU\\]\u002F European Economic Area \\[EEA\\]), OR\n   2. Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD).\n\nExclusion Criteria:\n\nPsA and PsO:\n\n1. The participant has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia.\n2. The participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO).","ALL","18 Years",{"count":20,"type":21},1088,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO).\n\nThe main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs.\n\nThe participants will be treated with either zasocitinib, active comparator, or placebo. Participants will be in the study for up to 60 weeks.",[27],"Psoriatic Arthritis",[29,30,31,32],"Drug Therapy","Latitude Research Program","Latitude PsA","Latitude PsA-3001","RECRUITING","2026-06-26",{"date":36,"type":37},"2026-06-29","ACTUAL",{"date":39,"type":37},"2025-03-03",{"date":41,"type":21},"2028-01-28",{"name":43,"class":44},"Takeda","INDUSTRY",188,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100567692","phase-3-a-study-of-zasocitinib-in-adults-with-psoriatic-arthritis-who-have-or-have-not-been-treated-with-biologic-medicines-100567692","NCT06671496","A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines","A Multi-Center, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Stratified by Prior Biologic Use (LATITUDE-PsA-3002)","Inclusion Criteria:\n\nAge:\n\n1. The participant is aged 18 years or older at the time of signing the informed consent form (ICF).\n\n   Disease Characteristics:\n2. The participant has a diagnosis of PsA.\n3. The participant must have signs and symptoms of PsA for at least 3 months prior to screening.\n4. The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).\n5. The participant has active arthritis as shown by a minimum of \\>=3 tender joints in TJC68 and \\>=3 swollen joints in SJC66 at the screening and baseline (Day 1) visits.\n6. The participant has at least 1 active lesion of plaque PsO \\>=2 cm in diameter, or any nail or nail bed changes characteristic of PsO.\n\n   Medications for PsA:\n7. The participant has had at least one of the following:\n\n   1. Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (not applicable in the European Union \\[EU\\]\u002F European Economic Area \\[EEA\\]), OR\n   2. Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD), OR\n   3. Biological disease-modifying antirheumatic drug (DMARD)-inadequate response (Bio-IR): Inadequate response to up to 2 biologic DMARDs.\n\nExclusion Criteria:\n\nPsA and PsO:\n\n1. The participant has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia.\n2. The participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO).",{"count":54,"type":21},600,[24],"Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO).\n\nThe main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA based on their previous experience with specific treatments.\n\nThe participants will be treated with either zasocitinib, or placebo. Participants will be in the study for up to 60 weeks.",[27],[29,30,31,59],"Latitude PsA-3002",{"date":36,"type":37},{"date":62,"type":37},"2025-03-10",{"date":64,"type":21},"2028-01-26",{"name":43,"class":44},122,{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":89},"100630383","phase-2-study-to-evaluate-tulisokibart-in-adults-with-psoriatic-arthritis-mk-7240-015-100630383","NCT07486960","Study to Evaluate Tulisokibart in Adults With Psoriatic Arthritis (MK-7240-015)","A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Psoriatic Arthritis.","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a clinical diagnosis of PsA and fulfillment of the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at Screening, with symptom onset ≥6 months before Screening.\n* Has a diagnosis of active plaque psoriasis or documented history of plaque psoriasis.\n* Has history of biologic disease-modifying antirheumatic drug (bDMARD)-naïve or bDMARD-inadequate response\u002Fintolerant.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than PsA (such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, myositis, etc), or any other conditions that may, in the judgment of the investigator, interfere with the assessment of PsA.\n* Has a skin condition diagnosis, other than psoriasis that may, in the judgment of the investigator, interfere with the assessment of psoriasis.\n* Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\\u003C5 years before Randomization.\n* Has any active infection.\n* Has known allergies, hypersensitivity, or intolerance to tulisokibart of its excipients.","80 Years",{"count":76,"type":21},140,[78],"PHASE2","Researchers are looking for new ways to treat Psoriatic Arthritis (PsA). This study will help find out if a study medicine called tulisokibart (MK-7240) can treat symptoms of active PsA. This study assesses the efficacy, safety, and tolerability of tulisokibart in adult participants with active PsA.\n\nIn this study, researchers will look at different doses of tulisokibart. Researchers want to learn if at least one of the study doses of tulisokibart works better than a placebo to lessen PsA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.",[27],"2026-06-25",{"date":36,"type":37},{"date":84,"type":37},"2026-04-20",{"date":86,"type":21},"2030-01-11",{"name":88,"class":44},"Merck Sharp & Dohme LLC",45,{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100615240","phase-1-a-study-to-learn-if-bimekizumab-given-in-different-ways-is-safe-and-moves-similarly-throughout-the-body-over-time-in-adults-100615240","NCT07290036","A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults","An Open-label, Randomized, Parallel-group, Noninferiority Study to Evaluate the Pharmacokinetics of Bimekizumab Administered Intravenously or as a Subcutaneous Injection in Participants With Active Psoriatic Arthritis and\u002For Active Axial Spondyloarthritis","Inclusion Criteria:\n\n1. Be 18+ years old and legally able to consent\n2. Have active psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA), suitable for bimekizumab treatment\n3. Weigh between 45-100 kg (females) or 50-100 kg (males).\n4. Be biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve or have stopped bDMARDs ≥3 months or 5 half-lives ago\n\nExclusion Criteria:\n\n1. Serious organ system disorders (e.g., heart, liver, kidney, gastrointestinal, neuro)\n2. Severe psychiatric issues or substance abuse in the past year\n3. Recent or chronic infections, including tuberculosis (TB) or nontuberculous mycobacterium (NTMB)\n4. Other inflammatory diseases (e.g., rheumatoid arthritis (RA), lupus, inflammatory bowel disease (IBD))\n5. Recent live vaccines (within 8 weeks) or Bacillus Calmette-Guerin (BCG) (within 1 year)\n6. Recent use of glucagon-like peptide-1 (GLP-1) agonists (within 28 weeks)",{"count":98,"type":21},392,[100],"PHASE1","To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.",[27,103],"Axial Spondyloarthritis",[105],"Bimekizumab, BKZ, Phase 1B","2026-06-18",{"date":108,"type":37},"2026-06-22",{"date":110,"type":37},"2025-12-10",{"date":112,"type":21},"2028-09-14",{"name":114,"class":44},"UCB Biopharma SRL",62,{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":126,"conditions":127,"keywords":128,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},"100614935","phase-3-continuation-study-of-zasocitinib-in-adults-with-psoriatic-arthritis-100614935","NCT07286058","Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis","A Phase 3, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Either Biologic DMARD-Naïve or Biologic DMARD-Experienced, Including Those With Inadequate Response to Biologic DMARDs","Inclusion Criteria:\n\n1. The participant is aged 18 years or older at the time of signing the informed consent form (ICF). In South Korea, the age requirement for adult participants is \\>=19 years of age.\n2. The participant has completed the 52-week treatment period in one of the parent studies (TAK-279-PsA-3001 or TAK-279-PsA-3002) independent of treatment assignment, and without meeting the criteria for permanent discontinuation of trial intervention defined in the parent studies.\n3. The participant must be deemed by the investigator to benefit from continued or newly initiated (that is, for participants randomized to active comparator in parent study TAK-279-PsA-3001) zasocitinib therapy.\n\nExclusion Criteria:\n\n1. Any participant who is deemed by the investigator to be not benefiting from the trial intervention based upon lack of improvement or worsening of their symptoms in the respective parent study.\n2. Any participant who met the criteria for permanent discontinuation of trial intervention defined in the parent studies (TAK-279-PsA-3001 or TAK-279-PsA-3002).\n3. The participant has developed any disease(s) that might confound the evaluations of benefit of zasocitinib therapy since enrollment in the respective parent study, including but not limited to rheumatoid arthritis, axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia.\n4. The participant has developed evidence of a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO).",{"count":124,"type":21},1182,[24],"Psoriatic arthritis (PsA) is a long-term inflammatory disease that affects the joints and skin.\n\nThe purpose of this study is to check how safe zasocitinib is, how well it is tolerated and how well it works in adults with PsA over a longer period of time.\n\nAdults who completed the 1-year (52-week) treatment period in one of the parent studies (TAK-279-PsA-3001 \\[NCT06671483\\] or TAK-279-PsA-3002 \\[NCT06671496\\]) may be able to join this continuation study (also called long-term extension or LTE study). All participants in this continuation study, will receive zasocitinib (lower or higher dose), once a day (QD).\n\nEach participant can be in this study for approximately 2 years (108 weeks). This includes a treatment period of up to 2 years (104 weeks) and a 1-month (4-week) follow-up period to monitor a participant's health.",[27],[29,31,129],"Latitude PsA-3003","2026-06-16",{"date":132,"type":37},"2026-06-17",{"date":134,"type":37},"2026-03-11",{"date":136,"type":21},"2029-12-18",{"name":43,"class":44},16,{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":172},"100348403","phase-1-testing-an-immunotherapy-anti-cancer-drug-nivolumab-for-advanced-cancers-in-patients-with-autoimmune-disorders-aim-nivo-100348403","NCT03816345","Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO","A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)","Inclusion Criteria:\n\n* Patients can have either histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable, or have a malignancy for which a PD-1\u002FPD-L1 inhibitor has been approved in the adjuvant setting, as well as the neoadjuvant or perioperative setting in which such treatment is considered standard of care or has been approved. Eligible tumor types include solid tumors and malignancies in which there is known evidence of clinical activity for single agent PD-1 or PD-L1 antibodies. Nivolumab or other PD1\u002FPD-L1 inhibitors are FDA-approved for the treatment of melanoma, non-small cell lung cancer (NSCLC), Merkel cell cancer, bladder cancer, renal cell carcinoma (RCC), gastric cancer, hepatocellular carcinoma (HCC), cervical cancer, head and neck cancer, Hodgkin lymphoma (HL), metastatic small cell lung cancer (SCLC), and any solid tumor with microsatellite instability (MSI)-high status confirmed. Patients with HL are eligible but must follow standard response criteria. Additional tumor types may be eligible on a case by case basis upon discussion with principal investigator (PI)\n\n  * Patients enrolling on the trial for adjuvant use will be restricted to those with histology for which a PD-1\u002FPD-L1 inhibitor has been approved in the adjuvant setting including but not limited to NSCLC, melanoma, RCC, cervical cancer, and bladder cancer\n  * Patients enrolled on the study can receive Nivolumab with other FDA-approved combinations according to the FDA package insert, including, but not limited to ipilimumab, cabozantinib or chemotherapy\n* Patients who have previously received other forms of immunotherapy (high-dose \\[HD\\] IL-2, IFN, CTLA-4) are allowed. Patients must not have received cytokine immunotherapy for at least 4 weeks before nivolumab administration. Patients who have received prior anti-CTLA4 will be allowed and the washout period is 6 weeks\n* Age \\>= 18 years; children are excluded from this study but may be eligible for future pediatric phase 1 combination trials\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky \\>= 60)\n* Life expectancy of greater than 12 weeks\n* Leukocytes \\>= 1,000\u002FmcL\n* Absolute neutrophil count \\>= 500\u002FmcL\n* Platelets \\>= 50,000\u002FmcL\n* Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 5 x institutional ULN or =\\\u003C 8 x institutional ULN for patients with liver metastases or an autoimmune disease that is contributing to the elevation of these values\n* Creatinine ULN OR glomerular filtration rate (GFR) \\>= 30 mL\u002Fmin (if using the Cockcroft-Gault formula)\n* Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated\n* If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required for at least 4 weeks (or scheduled assessment after the first cycle of treatment), and a risk-benefit analysis (discussion) by the patient and the investigator favors participation in the clinical trial\n* The effects of nivolumab on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product\n\n  * Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception\n  * WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), tubal ligation, or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU\u002FmL\n  * These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days, and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days\n  * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately. Patients can resume treatment upon termination of a pregnancy or the completion of a successful pregnancy\n* Ability to understand and the willingness to sign a written informed consent document\n* Patients with more than one autoimmune disease are eligible. The treating physician would determine which autoimmune disease is dominant and the patient would be treated under that specific cohort (Please note: Patients with more than one autoimmune disease should receive assessments for all previously diagnosed autoimmune diseases. For example, a patient with psoriasis and IBD might be enrolled in the IBD cohort. Disease assessments for both psoriasis and IBD should be obtained, as per protocol. Case report forms \\[CRFs\\] for all relevant autoimmune diseases should be utilized. However, all additional cohort requirements will be considered optional and only the assessments from the assigned cohort will be considered mandatory)\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients with known SSc or DM according to updated classification criteria (Van den Hoogan et al., Arthritis Rheum 2013;65(11):2737-47; Lundberg et al., A\\&R in press). Overlap features are permitted, but patients must meet criteria for a \"primary diagnosis\" of DM or SSc\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for DM or SSc unless specifically excluded\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients must have a baseline computed tomography (CT) of the chest (within 6 months of study entry)\n* RA-SPECIFIC INCLUSION: Rheumatologist-diagnosed RA requiring prior treatment with disease-modifying antirheumatic drugs (DMARDs) before patient was diagnosed with current malignancy. We recommend, but do not require, documentation for meeting 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria for RA\n* RA-SPECIFIC INCLUSION: Prednisone up to 10 mg\u002Fday will be allowed. Intraarticular steroids will be allowed for the treatment of new symptomatic joints\n* RA-SPECIFIC INCLUSION: Nonsteroidal anti-inflammatory drugs (NSAIDs) will be allowed\n* SLE-SPECIFIC INCLUSION: SLE diagnosed by a rheumatologist. The patient should meet the revised 1997 American College of Rheumatology (ACR) classification criteria for SLE, but this is not mandatory\n* ULCERATIVE COLITIS (UC)-SPECIFIC INCLUSION: Diagnosis of UC must be made by endoscopy with biopsies\n* UC-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administration\n* UC-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (antigen \\[Ag\\] negative, antibody \\[core (c)Ab\\] negative, antibody \\[surface (s)Ab\\] positive or negative) and Mycobacterium tuberculosis (purified-protein- derivative \\[PPD\\] or enzyme-linked immunospot assay \\[ELISpot or T-spot\\]) or be on appropriate anti-microbial treatment for these infections\n* UC-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission, defined as a Mayo Clinic score (MCS) of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 either without medications, or treated with 5-ASA derivative, probiotic, or prior fecal transplant\n* UC-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on 6-mercaptopurine, azathioprine, methotrexate, or rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohort\n* UC-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either be A) in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on a biologic therapy targeting tumor necrosis alpha (TNF-α) (infliximab, adalimumab, golimumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease defined as a MCS of 3-5 and no subscore higher than 2, and an endoscopic subscore of \\\u003C 2 on one of the medications or combination of medications defined for the Moderate or Mild cohort\n* CROHN'S DISEASE (CD)-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administration\n* CD-SPECIFIC INCLUSION: If patients have prior known disease in the stomach or small intestines, appropriate endoscopic evaluation (esophagogastroduodenoscopy\u002Fvideo capsule endoscopy) and\u002For imaging (computed tomography or magnetic resonance enterography) must also be current within 4 weeks prior to nivolumab administration\n* CD-SPECIFIC INCLUSION: Deep enteroscopy techniques, such as double balloon enteroscopy, will not be required\n* CD-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (sAg negative, cAb negative, sAb positive or negative) and M. tuberculosis (PPD or ELISpot or T-spot) or be on appropriate anti-microbial treatment for these infections\n* CD-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission as defined by a Crohn's Disease Activity Index (CDAI) \\\u003C 150 either without treatment or on a 5-ASA derivative, probiotic, antibiotics, or following fecal transplant\n* CD-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission as defined by a CDAI \\\u003C 150 on 6-mercaptopurine, azathioprine, methotrexate, rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohort\n* CD-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either A) be in clinical remission as defined by a CDAI \\\u003C 150 on biologic therapy targeting TNF-α (infliximab, adalimumab, certolizumab pegol), IL-12\u002F23p40 (ustekinumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease as defined by a CDAI of 150 to 220 on one of medications or combination of medications defined for the Moderate or Mild cohort\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For other autoimmune diseases that cannot be classified, the eligibility criteria will be determined by the managing rheumatologist or other autoimmune disease specialist, based on the clinical judgement and current American College of Radiology (ACR) classification guidelines or other relevant guidelines, as per the disease category in question\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For giant cell arteritis (GCA), patients must have had positive temporal artery biopsy for GCA and abnormal erythrocyte sedimentation rate (ESR) at time of diagnosis\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For polymyalgia rheumatica (PMR), patients must have clinical diagnosis in addition to elevated inflammatory markers including (ESR, C reactive protein \\[CRP\\])\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: Patients can be in remission (with no glucocorticoids or immunosuppressive medications) or have low-moderate activity, which is defined as being on prednisone ≤ 10 mg or equivalent\n* MS-SPECIFIC INCLUSION: Patients must meet 2017 McDonald criteria for the diagnosis of MS (Thompson AJ, et al. Diagnosis of multiple sclerosis: 2017 revision of the McDonald criteria. Lancet Neurol. 17(2):162-173.)\n* MS-SPECIFIC INCLUSION: Patients with MS can be in remission and can have a history of being on immunomodulatory agents, but at the time of entry into the clinical trial, patients should be off any concurrent MS therapy for at least 2 weeks. Patients receiving concomitant interferon gamma (IFN-γ treatment) will be permitted in the study\n* SJS-SPECIFIC INCLUSION: SjS diagnosed by a rheumatologist or oral medicine provider. The patient should meet the American-European Consensus Criteria for Sjögren's Syndrome (Vitali, et al., 2002). If on treatment, the patient may only be on hydroxychloroquine and prednisone ≤ 10 mg or equivalent\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients with known PsO as diagnosed by a dermatologist or PsA by a rheumatologist and\u002For by Classification for Psoriatic Arthritis (CASPAR) criteria (Tillett et al., 2012)\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients must have stable disease as determined by the investigator with no change in systemic therapy and\u002For biologic therapy for at least 3 months, except for those on tumor necrosis factor (TNF) inhibitors. In the case of TNF inhibition, patients may have transitioned to an alternative biologic therapy with stable disease for at least 4 weeks. For PsA, no change in corticosteroid therapy for at least 1 month prior to baseline and dose must be 10 mg or less\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for PsO or PsA unless specifically excluded\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (AEs) due to agents administered more than 4 weeks earlier have not resolved or stabilized. Palliative (limited-field) radiation therapy (RT) is permitted (2 week washout from start of treatment), if all of the following criteria are met:\n\n  * Repeat imaging demonstrates no new sites of bone metastases\n  * The lesion being considered for palliative radiation is not a target lesion\n* Patients with prior therapy with an anti-PD-1 or anti-PD-L1\n* Patients with prior allogeneic hematologic transplant\n* Patients who are receiving any other anticancer investigational agents\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* UC-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment\n* UC-SPECIFIC EXCLUSION: Prior colectomy\n* UC-SPECIFIC EXCLUSION: Concurrent primary sclerosing cholangitis (PSC). Patients with PSC can be enrolled on the Other Autoimmune Diseases Cohorts\n* UC-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup\n* CD-SPECIFIC EXCLUSION: Known untreated abscesses, untreated and symptomatic strictures, short gut physiology, or isolated jejunal disease\n* CD-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment\n* CD-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup\n* MS-SPECIFIC EXCLUSION: Patients with MS cannot have medical contraindications to gadolinium-enhanced magnetic resonance imaging (MRI)",{"count":147,"type":21},300,[100],"This phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in treating patients with autoimmune disorders and cancer that has spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced), to other places in the body (metastatic) or cannot removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Cabozantinib is a type of tyrosine kinase inhibitor and a type of angiogenesis inhibitor. Chemotherapy drugs, such as platinum containing therapies and fluoropyrimidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab alone and in combination with other treatments, including ipilimumab, cabozantinib, platinum containing therapy, or fluoropyrimidine, may be safe, tolerable, and\u002For effective in treating patients with autoimmune disorders and advanced, metastatic, or unresectable cancer.",[151,152,153,154,155,156,157,158,27,159,160,161,162,163],"Autoimmune Disease","Crohn Disease","Dermatomyositis","Hematopoietic and Lymphoid Cell Neoplasm","Inflammatory Bowel Disease","Malignant Solid Neoplasm","Multiple Sclerosis","Psoriasis","Rheumatoid Arthritis","Sjogren Syndrome","Systemic Lupus Erythematosus","Systemic Scleroderma","Ulcerative Colitis",{"date":132,"type":37},{"date":166,"type":37},"2019-07-16",{"date":168,"type":21},"2028-03-30",{"name":170,"class":171},"National Cancer Institute (NCI)","NIH",52,{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":22,"phases":183,"briefSummary":185,"conditions":186,"keywords":187,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":200},"100641914","transcutaneous-auricular-vagus-nerve-stimulation-in-psoriatic-arthritis-100641914","NCT07653009","Transcutaneous Auricular Vagus Nerve Stimulation in Psoriatic Arthritis","The Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Disease Activity and Related Clinical Parameters in Patients With Psoriatic Arthritis","Inclusion Criteria:\n\n* Diagnosis of psoriatic arthritis according to the CASPAR criteria\n* Age between 18 and 65 years\n* Stable treatment regimen for at least 12 weeks prior to enrollment\n* Visual Analog Scale (VAS) pain score ≥4 on a 0-10 scale\n* Moderate-to-high disease activity according to the Disease Activity Index for Psoriatic Arthritis (DAPSA)\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Presence of an implanted cardiac device (e.g., pacemaker, implantable cardioverter-defibrillator) or implanted neurostimulator\n* History of epilepsy or other uncontrolled neurological disorders\n* Active severe infection or immunosuppressive condition (e.g., sepsis)\n* Pregnancy or breastfeeding\n* Presence of deep auricular injury, previous ear surgery, or active skin lesions involving the auricle\n* Inability to comply with the treatment protocol or history of severe psychiatric disorders","65 Years",{"count":182,"type":21},15,[184],"NA","This prospective single-center interventional study aims to investigate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on disease activity, pain, quality of life, autonomic dysfunction symptoms, and inflammatory biomarkers in patients with psoriatic arthritis (PsA). Participants diagnosed with PsA according to the Classification Criteria for Psoriatic Arthritis (CASPAR) will undergo non-invasive auricular vagus nerve stimulation using the Vagustim device. Clinical outcomes including the Disease Activity Index for Psoriatic Arthritis (DAPSA), Ankylosing Spondylitis Disease Activity Score based on C-reactive protein (ASDAS-CRP), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), pain scores, sleep quality, quality of life, anxiety\u002Fdepression, and inflammatory markers including C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) will be evaluated before and after treatment.",[27],[188,189,190],"Transcutaneous Auricular Vagus Nerve Stimulation","Vagus Nerve Stimulation","Autonomic Dysfunction Disease Activity","2026-06-11",{"date":132,"type":37},{"date":194,"type":37},"2026-06-02",{"date":196,"type":21},"2027-08-02",{"name":198,"class":199},"Marmara University","OTHER",1,{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":22,"phases":210,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":5},"100582493","phase-4-a-study-to-investigate-effectiveness-of-tirzepatide-following-initiation-of-ixekizumab-in-participants-with-active-psoriatic-arthritis-and-overweight-or-obesity-in-clinical-practice-together-amplify-psa-100582493","NCT06864026","A Study to Investigate Effectiveness of Tirzepatide Following Initiation of Ixekizumab in Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice (TOGETHER AMPLIFY-PsA)","A Phase 4, Prospective, Open-Label, Single-Arm Study to Assess the Effectiveness of Tirzepatide After Initiation of Ixekizumab in Adult Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice.","Inclusion Criteria:\n\n* Have a diagnosis of active psoriatic arthritis (PsA) as defined by a rheumatologist or other healthcare professional (HCP) experienced in treating PsA.\n* Body Mass Index (BMI) of 30 kilograms per meter squared (kg\u002Fm²) or greater (obesity) or 27 kg\u002Fm2 to \\\u003C30 kg\u002Fm² (overweight) in the presence of at least 1 weight-related comorbid condition (hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease).\n* Who have been treated with ixekizumab for approximately 3 months (±1 month) prior to decision to add tirzepatide.\n* Must be able to initiate tirzepatide (Day 0) within 30 days of treatment decision (baseline or screening).\n\nExclusion Criteria:\n\n* Have currently received ixekizumab for more than 4 months or less than 2 months.\n* Had any exposure to tirzepatide or other glucagon-like peptide-1 (GLP-1) receptor agonist (for example, dulaglutide, liraglutide, or semaglutide).\n* Are currently enrolled in any other clinical study.\n* Have a known hypersensitivity to any component of tirzepatide.\n* Have a personal or family history of medullary thyroid cancer.\n* Have multiple endocrine neoplasia type 2.\n* Have type 1 diabetes mellitus.\n* Have a history of chronic or acute pancreatitis at any time before screening.\n* Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that requires acute treatment.\n* Have a history of ketoacidosis or hyperosmolar state\u002Fcoma.\n* Have a history of severe hypoglycemia unawareness within the 6 months before screening.\n* Have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea\u002Fvomiting.",{"count":209,"type":21},200,[211],"PHASE4","The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with active PsA and obesity or overweight with at least 1 weight-related comorbidity.\n\nThe study will last up to 12 months.",[27,214],"Overweight or Obesity","2026-06-09",{"date":191,"type":37},{"date":218,"type":37},"2025-03-06",{"date":220,"type":21},"2027-11",{"name":222,"class":44},"Eli Lilly and Company",{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":200},"100561140","elucidating-shared-mechanisms-contributing-to-nafld-and-psa-disease-severity-with-guselkumab-therapy-100561140","NCT06586281","Elucidating Shared Mechanisms Contributing to NAFLD and PsA Disease Severity With Guselkumab Therapy","Elucidating Shared Mechanisms Contributing to Non-Alcoholic Fatty Liver Disease (NAFLD) and Psoriatic Arthritis (PsA) Disease Severity With Guselkumab Therapy","Inclusion Criteria:\n\n1. Adults with diagnosis of PsA fulfilling the classification for PsA (CASPAR) criteria.\n2. Must have:\n\n1 or more swollen joint(s) and\u002For one or more active sites of enthesitis\n\n3\\. AND\u002FOR\n\n1 or more psoriatic plaques\n\n4\\. No changes in the regular medication regimen within the last three months, and no use of systemic and\u002For chronic steroids within 8 weeks leading up to the study.\n\n5\\. Overweight or obese by BMI ≥ 25.0 kg\u002Fm2 or ≥ 23.0 for Asian participants\n\n6\\. Patients are starting Guselkumab therapy for PsA as indicated by primary rheumatologist\n\n7\\. Elevated liver fat on controlled attenuation parameter (CAP) ≥ 288 dB\u002Fm, which is consistent with NAFLD after exclusion of secondary causes of liver disease.\n\nExclusion Criteria:\n\n1. Patients with prior exposure to IL12\u002F23i, IL-17i, JAKi, or TYK2i. Patients with exposure to more than 2 TNFi.\n2. Evidence of other causes of chronic liver disease\n\n   * Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg).\n   * Previous or current infection with Hepatitis C as defined by presence of hepatitis C virus Abin serum (anti-HCV Ab).\n   * Autoimmune hepatitis as defined by anti-nuclear antibody (ANA) of 1:160 or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy.\n   * Autoimmune cholestatic liver disorders as defined by elevation of alkaline phosphatase and anti-mitochondrial antibody of greater than 1:80 or liver histology consistent with primary biliary cirrhosis or elevation of alkaline phosphatase and liver histology consistent with sclerosing cholangitis.\n   * Wilson disease as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease.\n   * Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency.\n   * Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y or compound heterozygosity for C282Y\u002FH63D.\n   * Drug-induced liver disease as defined on the basis of typical exposure and history.\n   * Bile duct obstruction as shown by imaging studies.\n   * History of gastrointestinal bypass surgery or ingestion of medications known to produce steatosis, such as corticosteroids, high-dose estrogen, tamoxifen, amiodarone or tetracycline in the previous 6 months.\n   * Evidence of cirrhosis or previously known cirrhosis based on the results from previous liver biopsy or history of portal hypertension presented by ascites, hepatic encephalopathy or varices\n   * Presence of regular and\u002For excessive use of alcohol (defined as \\>30g\u002Fday for males and \\>15g\u002Fday for females) for a period longer than 2 years at any times in the last 10 years\n   * Serum creatinine \\> 2.0 mg\u002FdL\n   * The subject is a pregnant or nursing female or is planning to become pregnant\n   * Life expectancy less than 5 years\n3. History of known HIV infection",{"count":231,"type":21},20,[184],"While many studies examine Nonalcoholic fatty liver disease (NAFLD), little is known about its progression to high-risk nonalcoholic steatohepatitis (NASH) in PsA patients. Shared disease mechanisms may explain the increased severity in PsA. This study involves two visits from PsA patients with NAFLD and active disease signs (e.g., swollen joint, enthesitis, or psoriatic plaque). It aims to assess the impact of biological therapies on liver disorders, joints, and skin in PsA patients.",[27],"2026-06-08",{"date":237,"type":37},"2026-06-10",{"date":239,"type":37},"2025-06-01",{"date":241,"type":21},"2027-12-01",{"name":243,"class":199},"University of California, San Diego",{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":252,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":22,"phases":255,"briefSummary":256,"conditions":257,"keywords":259,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":272},"100545449","modifying-pest-for-psoriatic-arthritis-screening-100545449","NCT06382051","Modifying PEST for Psoriatic Arthritis Screening","A Multicenter, Prospective, Study to Evaluate the Impact of Modifying the Validated Psoriasis Epidemiology Screening Tool (PEST) on the Potential Diagnosis of Psoriatic Arthritis in Adult Patients With Moderate-to-severe Plaque Psoriasis in Canada (\"ScreenX\")","ScreenX","Key inclusion criteria:\n\n1. Moderate-to-severe plaque PsO patients who are candidates for bDMARDs, according to physician's clinical judgement at the time of patient enrollment.\n2. Adult patients at the time of informed consent signature\n3. Patients able to understand and willing to comply with protocol requirements, instructions, and restrictions\n4. Residents of Canada\n\nKey exclusion criteria:\n\n1. Patients who have previously screened positive for PsA through PEST.\n2. Patients who have been diagnosed with PsA.\n3. Patients who have been diagnosed with inflammatory arthritis unrelated to PsA (rheumatoid arthritis, reactive arthritis, enteropathic arthritis, axial spondyloarthritis)\n4. Patients treated with a bDMARD for moderate-to-severe plaque PsO or any other medical condition within the last 6 months prior to patient enrollment.",true,{"count":254,"type":21},502,[184],"The purpose of this study is to assess the impact of adding two questions and pictures to the validated PEST on the potential diagnosis of PsA in participants with moderate-to-severe plaque PsO in Canada.",[258,27],"Plaque Psoriasis",[158,27,260,258,261,262,263],"PsA","PsO","Implementation Science","Psoriasis Epidemiology Screening Tool",{"date":265,"type":37},"2026-06-03",{"date":267,"type":37},"2025-01-23",{"date":269,"type":21},"2026-08-28",{"name":271,"class":44},"Novartis Pharmaceuticals",29,{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":252,"sex":17,"minAge":18,"maxAge":281,"enrollmentInfo":282,"targetDuration":4,"studyType":22,"phases":284,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":200},"100462909","cytokine-expression-in-psoriasis-patients-with-and-without-joint-involvement-100462909","NCT05307809","Cytokine Expression in Psoriasis Patients With and Without Joint Involvement","Cytokine Expression in Sera, ex Vivo Stimulated Peripheral Blood Mononuclear Cells Culture, and Skin in Psoriasis - Comparison of Patients With and Without Joint Involvement","CYNEPSA","Inclusion criteria:\n\n* For psoriasis patients :\n\n  * Age over 18 years old\n  * Signed informed consent\n  * 5 year old psoriasis at least\n  * At least one skin lesion over 2 cm\n  * Without any articular symptoms\n  * Without any DMARDs\n  * Without anticoagulant treatments or coagulation disease\n  * With normal articular and enthesis sonography\n* For psoriatic arthritis patients :\n\n  * Age over 18 years old\n  * Signed informed consent\n  * Psoriatic arthritis according to CASPAR criteria\n  * Without any DMARDs\n  * Without anticoagulant treatments or coagulation disease\n  * With at least one synovitis at inclusion\n* For controls\n\n  * Age and sex matched with a patient without any rheumatic or dermatologic medical conditions\n  * No treatment with corticosteroïds or non-steroïdial anti-inflammatory drugsAge over 18 years old\n\nExclusion criteria:\n\n▪ For psoriasis patients :\n\n* Joint damage according to CASPAR criteria\n* Echography activity in favor of chronic inflammatory rheumatism\n* For patients and controls:\n* Without social protection rights\n* People under judiciary protection, of less than 18 years old, pregnant woman, breast feeding women, jailed patients.","100 Years",{"count":283,"type":21},40,[184],"The objective of the resarch is to study the cytokine profile of patients with psoriatic arthritis and psoriasis in order to better understand the pathophysiology of the disease and the contribution of cytokines to the presence or absence of joint involvement. This research will compare cytokines levels in sera, in PBMC culture after LPS or CD3\u002FCD28 agonist antibodies, and in skin biopsy.",[158,27],"2026-05-21",{"date":289,"type":37},"2026-05-26",{"date":291,"type":37},"2022-08-17",{"date":293,"type":21},"2026-08-18",{"name":295,"class":199},"Poitiers University Hospital",{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":306,"phases":4,"briefSummary":307,"conditions":308,"keywords":4,"overallStatus":310,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":4},"100639246","inflammation-digital-biomarkers-validation-study-100639246","NCT07594054","Inflammation Digital Biomarkers Validation Study","IDBV: Inflammation Digital Biomarker Validation Study","IDBV","Inclusion Criteria:\n\nPreviously consented to take part in the HPOS study and have agreed to be contacted for future ethically approved studies.\n\nAdults with psoriasis with no diagnosis of PsA.\n\nHave a compatible smartphone\n\nHave a good command of local language\n\nExclusion Criteria:\n\nParticipants not consented into the HPOS study\n\nDo not have use of a compatible smartphone\n\nAre not willing to use the smartphone app.\n\nAdults with a pre-existing diagnosis of PsA",{"count":305,"type":21},3458,"OBSERVATIONAL","HIPPOCRATES is an Innovative Medicines Initiative (IMI) funded EU Consortium established to address key unmet clinical needs in psoriatic disease. As part of the project, the HIPPOCRATES Prospective Observational Study (HPOS) is a study of patients with psoriasis which is recruiting across Europe. The study is led by a research team at University of Oxford and supported by a team at University College Dublin. This current study aims to identify people with psoriasis who are at risk of developing psoriatic arthritis. Up to one-third of patients with psoriasis will develop a related arthritis causing inflammation in the joints and tendons. The investigators want to identify which patients will develop arthritis with the long-term and ambitious aim of trying to prevent the development of arthritis before it occurs. The HPOS study is currently recruiting\u002Fapproaching adults with psoriasis and asking study participants to complete questionnaires every 6 months via a dedicated study website. The questionnaires include a 'screening questionnaire' to try to identify arthritis.\n\nAdults with psoriasis but without a pre-existing diagnosis of PsA are currently being recruited via clinics, national and international patient support organisations including those under the umbrella of EUROPSO, and media campaigns. Participants are recruited across Europe in the following countries: UK, Ireland, Italy, France, Spain, Denmark, Germany, Belgium, Netherlands, Sweden, Portugal, Greece, Norway, Switzerland, Poland and Romania. The University of Oxford is the sponsor for the study across all countries, but local regulations will be followed, and local ethical approval has been sought for each different country. Data is requested from participants every 6 months and they will be prompted by email.\n\nLikewise, the iPROLEPSIS consortium is a Horizon Europe funded consortium investigating digital biomarkers in PsA. In 2024, the consortium launched a study recruiting 600 patients with PsA across 4 counties, utilising digital biomarkers to identify disease flares. This includes the use of smartwatches, a mobile phone app and active video tests. This will allow us to develop algorithms to identify active disease.\n\nSimilar approaches are proposed for a study called the Inflammation Digital Biomarkers Study (IDBV) which will try to identify the onset of PsA in people living with psoriasis. Patients in HPOS who have given consent to be contacted about additional studies, will be offered the opportunity to join this study. They will complete an additional consent form and will download the miPROLEPSIS lite app to their mobile phone.\n\nThe Study app will passively collect data from the user's phone; participants do not need to perform any specific tasks apart from some initial configuration steps like logging in and connecting their wearables (Connecting a wearable is optional).\n\nThe investigators intend to run IDBV as a sub-study in HPOS and invite participants enrolled into the HPOS study who do not have a diagnosis of PsA.",[27,309],"Psoriasis (PsO)","NOT_YET_RECRUITING","2026-05-20",{"date":313,"type":37},"2026-05-22",{"date":315,"type":21},"2026-06",{"date":317,"type":21},"2027-12",{"name":319,"class":199},"University of Oxford",{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":306,"phases":4,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":200},"100420181","testing-of-an-educational-tool-for-patients-with-melanoma-and-pre-existing-autoimmune-disease-who-are-candidates-for-immune-checkpoint-inhibitors-100420181","NCT04751396","Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint Inhibitors","Testing of an Educational Tool for Patients With Melanoma and Concomitant Autoimmune Disease Who Are Candidates for Adjuvant Therapy With Immune Checkpoint Inhibitors: Acceptability and Usability With Patients and Providers","Inclusion Criteria:\n\n* Diagnosis of melanoma\n* Diagnosis of pre-existing autoimmune disease\n\n  * Inflammatory bowel disease\n\n    * Diagnosis of Crohn's disease or ulcerative colitis by a gastroenterologist\n    * For ulcerative colitis, proof of chronic changes over time (i.e., 6 months) and signs of inflammation histologically\n    * Treatment with aminosalicylates, corticosteroids, thiopurines, or immune modifiers (e.g., calcineurin inhibitors, methotrexate, adhesion molecule antagonists)\n  * Rheumatoid arthritis\n\n    * Diagnosis of rheumatoid arthritis by a rheumatologist\n    * Treatment with traditional disease-modifying antirheumatic drugs (e.g., methotrexate, sulfasalazine, hydroxychloroquine) or targeted therapy\n  * Systemic lupus erythematosus\n\n    * Diagnosis of systemic lupus erythematosus by a rheumatologist\n  * Psoriasis\n\n    * Diagnosis of psoriasis by a dermatologist\n    * Treatment with corticosteroids, vitamin D analogs, anthralin, topical retinoids, calcineurin inhibitors, salicylic acid, coal tar, or moisturizers; light therapy, including sunlight, ultraviolet B (UVB) phototherapy, narrowband UVB therapy, Goeckerman therapy, photochemotherapy, excimer laser, or pulsed dye laser; or systemic medications, including retinoids, methotrexate, cyclosporine, hydroxyurea, or thioguanine or targeted therapies\n  * Spondyloarthropathies\n\n    * Diagnosis of ankylosing spondylitis, reactive arthritis, psoriatic arthritis, or enteropathic arthritis\u002Fspondylitis by a rheumatologist\n    * Treatment with disease-modifying antirheumatic drugs (e.g., sulfasalazine) or targeted therapy\n* Age of 18 years or older\n* Patients whose physicians had recommended they begin using any of the currently available immune checkpoint inhibitors or people who are in the midst of or have already made the decision on whether or not start an immune checkpoint inhibitor\n* E-mail access and computer with Internet access or telephone\n* Ability to communicate in English or Spanish\n* CLINICIAN\n* Prescribed immune checkpoint inhibitors\n* Are providing care for patients with melanoma\n* In the clinics at MD Anderson",{"count":328,"type":21},125,"This study learn how easily patients can use an educational tool that will be created for patients with melanoma and pre-existing autoimmune diseases who receive or will receive immune checkpoint inhibitor drugs. Patients will be asked their opinions about the design, accessibility, and content of the tool. Researchers will use the information collected to improve the educational materials that will help patients make future decisions about their treatment.",[331,151,152,332,333,155,334,158,27,335,159,161,163],"Ankylosing Spondylitis","Enteropathic Arthritis","Enteropathic Spondylitis","Melanoma","Reactive Arthritis","2026-05-18",{"date":311,"type":37},{"date":339,"type":37},"2022-04-20",{"date":341,"type":21},"2027-02-02",{"name":343,"class":199},"M.D. Anderson Cancer Center",{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":352,"targetDuration":354,"studyType":306,"phases":4,"briefSummary":355,"conditions":356,"keywords":371,"overallStatus":310,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":200},"100636568","cartiz-registry-cartilage-arthropathy-and-imaging-under-tirzepatide-in-zone-stratified-cohorts---a-four-institute-mexican-observational-registry-100636568","NCT07567378","CARTIZ Registry: Cartilage, Arthropathy and Imaging Under Tirzepatide in Zone-stratified Cohorts - A Four-Institute Mexican Observational Registry","Cartilage, Arthropathy and Imaging Under Tirzepatide in Zone-stratified Cohorts (CARTIZ): A Prospective Observational Multi-Institutional Registry of the VAT-Articular-Cardiac-Aging Axis in Adults Exposed to Tirzepatide in Mexico, With Quantitative Knee Cartilage T2 Mapping, Cardiac CT Epicardial Adipose Tissue Radiomic Phenotyping, HLA Stratification, Longitudinal Multi-Frequency Bioimpedance Body Composition, and a Prespecified Surgical Tissue Acquisition Subcohort","CARTIZ","Inclusion Criteria:\n\n* 1\\. Age ≥18 years at the time of informed consent. 2. Currently receiving tirzepatide under an independent clinical indication (type 2 diabetes, insulin resistance, obesity with or without associated metabolic disease, renal protection, metabolic hypertension, or associated off-label metabolic use) prescribed by the treating physician independently of the registry.\n\n  3\\. Presence of at least one objectively documented musculoskeletal manifestation - current or historical - defined as any of: (i) inflammatory arthralgia affecting one or more joints with clinical, imaging, or serological support; (ii) CASPAR-positive psoriatic arthritis; (iii) radiographically documented knee osteoarthritis; (iv) enthesitis on physical examination or ultrasound; (v) documented inflammatory arthropathy of the spine or peripheral joints with a specialist diagnosis.\n\n  4\\. For the retrospective-prospective component: availability of clinical documentation of articular state prior to tirzepatide initiation in the patient's medical record. Documentation may include physical examination notes, imaging, laboratory values, or specialist consultation notes.\n\n  5\\. Signed informed consent for registry enrolment, longitudinal serum biobanking, HLA typing at INCMNSZ, quantitative knee MRI with T2 mapping at Ci3M UAM-Iztapalapa at Week 0 and Week 52, non-contrast cardiac CT at INCar at Week 0 and Week 52, multi-frequency bioelectrical impedance analysis at Universidad La Salle México at six timepoints, and (where applicable) medical record review. Each attestation is consented modularly within a single document.\n\n  6\\. Clinical plan to continue tirzepatide for at least 52 weeks from registry Week 0, based on the treating physician's evaluation of current clinical indication. Discontinuation during follow-up is captured as an outcome variable and does not remove the patient from the registry.\n\n  7\\. Capacity to attend scheduled follow-up visits and to undergo bilateral knee MRI at Ci3M (without severe claustrophobia requiring sedation, without absolute contraindication to MRI - see Exclusion 6) and non-contrast cardiac CT at INCar (without uncontrolled arrhythmia precluding ECG-gated imaging of diagnostic quality).\n\nFor the Surgical Tissue Subcohort (Cohort 3) only - additional criteria applied at the time of subcohort enrolment:\n\n8s. Scheduled clinically indicated cardiac surgery at the Instituto Nacional de Cardiología Ignacio Chávez (coronary artery bypass grafting, valve replacement, or combined procedures) during registry follow-up.\n\n9s. Specific additional informed consent for intraoperative collection of epicardial adipose tissue fragments.\n\nExclusion Criteria:\n\n* 1\\. Initiation or modification of a biologic disease-modifying antirheumatic drug (biologic DMARD) or JAK inhibitor within the 12 weeks prior to Week 0, or clinically anticipated initiation or modification during the first 12 weeks of follow-up. Washout may permit re-screening.\n\n  2\\. Major joint surgery within the 3 months prior to Week 0, or planned major joint surgery within the 12 months following Week 0, involving any joint scheduled for evaluation in the registry.\n\n  3\\. Intra-articular corticosteroid or hyaluronic acid injection within the 6 weeks prior to baseline biospecimen collection in any joint. Patients beyond the 6-week washout are eligible.\n\n  4\\. Active malignancy, with the exception of adequately treated non-melanoma skin carcinoma. History of malignancy in remission ≥5 years is permitted at the discretion of the treating investigator.\n\n  5\\. Current pregnancy, lactation, or planned pregnancy within the 12-month observation period.\n\n  6\\. Absolute contraindication to MRI, including non-MRI-compatible cardiac pacemaker or implanted defibrillator, ferromagnetic intracranial vascular clips, non-documented non-MRI-compatible cochlear implants, or other contraindication per the local MRI safety protocol.\n\n  7\\. Systemic rheumatologic disease other than psoriatic arthritis or osteoarthritis requiring active immunomodulation, specifically: seropositive rheumatoid arthritis on biologic therapy, active systemic lupus erythematosus on immunomodulation, active vasculitis on immunosuppression, or other systemic disease whose treatment confounds the inflammatory axis the registry is designed to characterize.\n\n  8\\. Inability to provide informed consent (cognitive impairment, language barrier not resolvable with site interpreter, or other incapacity to understand the protocol), or anticipated inability to complete the 52-week follow-up.\n\nFor the Surgical Tissue Subcohort (Cohort 3) only - additional exclusions:\n\n9s. Prior major cardiac surgery resulting in extensive pericardial adhesions that preclude safe intraoperative EAT fragment collection, as assessed by the operating cardiac surgeon.\n\n10s. Emergency cardiac surgery precluding the specific informed consent process.",{"count":353,"type":21},30,"52 Weeks","CARTIZ is a prospective observational clinical registry of adults in Mexico receiving tirzepatide (a dual GLP-1\u002FGIP receptor agonist) under an independent clinical indication - typically type 2 diabetes, insulin resistance, obesity, renal protection, metabolic hypertension, or associated off-label metabolic use. The registry is entirely observational: CARTIZ does not initiate, modify, interrupt, or supply tirzepatide, and does not dictate dose, route, or duration. All pharmacological exposure decisions are made by the treating physician independently of study participation. The registry is operationalized through a four-institute architecture integrating three Mexican National Institutes of Health and one national imaging laboratory. Core 1 (Knee Cartilage Imaging, Ci3M UAM-Iztapalapa) performs bilateral 3T MRI with quantitative T2 mapping at Week 0 and Week 52. Core 2 (Cardiac Imaging, Instituto Nacional de Cardiología Ignacio Chávez) performs non-contrast cardiac computed tomography for radiomic phenotyping of epicardial adipose tissue at Week 0 and Week 52 under cardiovascular Co-Principal Investigator Dr. Erick Alexánderson Rosas. Core 3 (HLA Typing, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Transplant Department) performs Class I and Class II HLA typing by PCR-SSO Reverse Luminex. Core 4 (Body Composition, Universidad La Salle México) performs multi-frequency bioelectrical impedance analysis (seca mBCA) at six longitudinal timepoints capturing visceral adipose tissue trajectory, phase-angle trajectory, appendicular skeletal muscle mass, and hydration ratios at zero marginal cost. The registry enrolls n=30 patients across three clinical sites with identical protocol (IMSS Clínica Río Magdalena, INCMNSZ outpatient clinic, and a private practice site in Mexico City), generating 60 evaluable knees and 30 paired cardiac CT studies. The primary co-endpoints address a mechanistic question no other tirzepatide study is positioned to answer: whether the articular response to tirzepatide in inflammatory arthropathy precedes and mechanistically precedes weight loss, through formal mediation analysis of Week-4 ACR20 response via high-sensitivity C-reactive protein, SERPINB2, and dipeptidyl peptidase-4 activity, restricted to the Mechanistic Analysis Set of patients with tirzepatide exposure ≤16 weeks at Week 0 and delta-BMI \\\u003C1.0 kg\u002Fm² through Week 4. A prespecified Surgical Tissue Subcohort is declared at initial registration to establish public scientific priority on direct human epicardial adipose tissue transcriptomic characterization under dual GIP\u002FGLP-1 receptor agonism. Subcohort participants who undergo clinically indicated cardiac surgery at INCar during follow-up (coronary artery bypass grafting, valve replacement, or combined procedures) are invited to provide specific additional informed consent for collection of epicardial adipose tissue fragments routinely excised during operative access and otherwise discarded as surgical waste. Operational launch is contingent on separate INCar tissue-specific approvals and will proceed via PRS record amendment when ready",[27,357,358,359,360,361,362,363,364,365,366,367,368,369,370],"Osteoarthitis","Knee","Diabetes (DM)","Type 2 Diabetes Mellitus (T2DM)","Obesity (Disorder)","Insulin Resistance Syndrome","Metabolic Syndrome","Heart Failure","Preserved Ejection Fraction","Coronary Artery Disease","Atrial Fibrillation (AF)","Non Alcholic Fatty Liver Disease","Sarcopenia","Pericardium",[372,373,374,375,376,377,378,379,380,381,382,383,384,385,386,387,388,389,390,391,392,393],"Tirzepatide","Dual GIP\u002FGLP-1 receptor agonist","Multi-nutrient-stimulated hormones","Psoriatic arthritis","Inflammatory arthropathy","ACR20","Cartilage T2 mapping","Quantitative knee MRI","Epicardial adipose tissue","Cardiac CT radiomics","Fat Attenuation Index","HLA typing","Visceral adipose tissue","Phase angle","seca mBCA","Bioelectrical impedance analysis","Mediation analysis","Weight-independent effect","Off-label exposure","Mexican registry","Epicardial adipose transcriptomics","Single-nucleus RNA sequencing","2026-05-07",{"date":396,"type":37},"2026-05-12",{"date":398,"type":21},"2026-05",{"date":400,"type":21},"2029-05",{"name":402,"class":199},"JULIO GRANADOS MONTIEL",{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":409,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":411,"minAge":18,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":22,"phases":413,"briefSummary":414,"conditions":415,"keywords":418,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":433},"100584350","phase-1-a-study-to-assess-the-concentration-of-bimekizumab-in-mature-breast-milk-from-mothers-receiving-treatment-with-bimzelx-bimekizumab-100584350","NCT06888193","A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)","A Multicenter Open-label, Prospective Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)","BE CARING","Inclusion Criteria:\n\n* Study participant must be at least 18 years of age at the time of signing the informed consent.\n* Study participant is being treated with commercial bimekizumab per locally approved prescribing information and in accordance with her treating physician.\n* Study participant is breastfeeding and intends to breastfeed throughout the Sampling Period.\n* The decision to treat with bimekizumab and to breastfeed is made independently from and prior to the study participant consenting to participate in the study.\n* Study participant must be on bimekizumab treatment for at least 12 weeks after delivery and since starting\u002Frestarting\u002Fcontinuing bimekizumab prior to sampling (prior to start of the Sampling Period).\n* A female study participant is eligible to participate if she is not pregnant and does not plan to become pregnant during the study.\n\nExclusion Criteria:\n\n* Study participant has any medical, obstetrical, or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study.\n* The infant has any abnormality noted on physical examination or medical history that, in the opinion of the Investigator, may jeopardize or compromise study participation.\n* Study participant has a history of chronic alcohol or drug abuse within the previous last year.\n* Study participant has history of breast implants, breast augmentation, or breast reduction surgery.\n* Study participant plans a surgical intervention during the Screening Period and Sampling Period or anticipates having surgery while participating in the Sampling Period (does not apply to tubal ligation).\n* Study participant or her infant has participated in another study of an investigational medicinal product (IMP) (and\u002For an investigational device) within the previous 6 months or is currently participating in another study of an IMP (and\u002For an investigational device), unless the study is UCB PS0036 or a bimekizumab registry study.\n* Study participant or her infant has previously participated (ie, entered the sampling period) in this study.","FEMALE",{"count":231,"type":21},[100],"Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.",[416,27,103,417],"Moderate to Severe Plaque Psoriasis","Hidradenitis Suppurativa",[419,420,421,422,423,424,260],"Bimekizumab","Breastfeeding mothers","Bimzelx®","PSO","HS","AxSpa","2026-04-30",{"date":427,"type":37},"2026-05-01",{"date":429,"type":37},"2025-11-05",{"date":431,"type":21},"2027-05-03",{"name":114,"class":44},12,{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":438,"acronym":439,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":22,"phases":443,"briefSummary":444,"conditions":445,"keywords":453,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":200},"100388150","deployment-o-the-multidisciplinary-prospective-cohort-imminent-100388150","NCT04334031","Deployment o the Multidisciplinary Prospective Cohort Imminent","IMMINeNT","Inclusion Criteria:\n\n* Patient followed for their IMID in one of the departments of the Lille University Hospital participating in the study (dermatology, internal medicine, neurology, pneumology and rheumatology)\n* Social insured\n* Have the capacity to understand the study requirements, provide written informed consent, and comply with the study data collection procedures.\n\nExclusion Criteria:\n\n* Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of coverage by the social security system.\n* Pregnant or breastfeeding woman\n* Persons deprived of liberty\n* Protected minors or adults\n* Persons who have refused or are incapable of giving informed consent\n* Persons in Emergency Situations",{"count":442,"type":21},2200,[184],"Immune-mediated inflammatory diseases (IMIDs) most often affect young patients and have high impact on morbidity and mortality with a significant alteration in the quality of life of patients with professional, social and emotional repercussions.\n\nBeyond this burden, IMIDs share many common pathophysiological mechanisms and treatments, known as \"targeted therapies\". Despite progress in this field, much remains to be done in clinical, therapeutic and fundamental research to address the efficacy, resistance and side-effects of treatment.\n\nThese similarities between IMIDs have led the FHU IMMINeNT to propose the creation of a prospective, multidisciplinary clinical-biological database (IMMINeNT cohort), associated to a biobank, of patients with IMIDs. The main objectives of this database will be to identify new prognostic and therapeutic biomarkers in order to develop new therapeutic targets and biomarkers, to identify prognostic factors and determinants related to the activity, severity and quality of life of patients with IMIDs as well as to the response and tolerance to treatment.",[446,447,448,449,450,27,157,451,452],"Chronic Inflammatory Disease","Angioedema","Severe Asthma","Lupus","Atopic Dermatitis","Systemic Sclerosis","Behçet Disease",[454,455,456,457,458],"Immune Mediated Inflammatory Diseases (IMIDs)","biomarker","cohort study","quality of life","disease severity","2026-04-28",{"date":461,"type":37},"2026-05-05",{"date":463,"type":37},"2020-07-20",{"date":465,"type":21},"2031-07-21",{"name":467,"class":199},"University Hospital, Lille",{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":474,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":476,"targetDuration":4,"studyType":22,"phases":478,"briefSummary":479,"conditions":480,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":491},"100550984","phase-4-a-study-to-evaluate-the-impact-of-upadacitinib-on-spondyloarthritis-outcomes-in-patients-with-active-psoriatic-arthritis-100550984","NCT06454188","A Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients With Active Psoriatic Arthritis","A Randomized, Placebo-controlled, Multicenter, Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients With Active Psoriatic Arthritis (UP-SPOUT)","UP-SPOUT","Inclusion Criteria:\n\n1. Subject ≥18 of age at the screening visit.\n2. Subject must be able to understand and willing to adhere to all protocol requirements and voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)\u002Finstitutional review board (IRB), prior to the initiation of any screening or study-specific procedures.\n3. Diagnosis of PsA by their treating rheumatologist.\n4. Classification of PsA according to the CASPAR criteria19: Inflammatory articular disease (joint, spine, or entheseal) AND at least 3 points of the following categories:\n\n   a) Evidence of psoriasis: (Score for one of the following) i) Current psoriasis - 2 points (Psoriatic skin or scalp disease present today as judged by a dermatologist or rheumatologist) ii) Personal history of psoriasis - 1 point (A history of psoriasis that may be obtained from the subject, family physician, dermatologist, rheumatologist, or other qualified health care provider) iii) Family history of psoriasis - 1 point (A history of psoriasis in a first- or second-degree relative according to subject report) b) Psoriatic nail dystrophy - 1 point i) Typical psoriatic nail dystrophy, including onycholysis, pitting, and hyperkeratosis, observed on current physical examination c) A negative test for rheumatoid factor - 1 point i) By any method except latex, but preferably by enzyme-linked immunosorbent assay (ELISA) or nephelometry, according to the local laboratory reference range d) Dactylitis: (Score for 1 of the following) i) Current dactylitis - 1 point (Swelling of an entire digit) ii) History of dactylitis - 1 point (A history of dactylitis recorded by a rheumatologist) e) Radiologic evidence of juxta-articular new bone formation - 1 point i) Ill-defined ossification near joint margins (but excluding osteophyte formation) on plain radiographs of the hand or foot.\n5. Evidence of axial involvement (e.g., active inflammation, structural changes) that has been demonstrated by previous imaging techniques (e.g., radiography, MRI, CT), is considered indicative of axial disease by central reader assessment (2 readers and adjudicator).\n6. Screening\u002Fbaseline MRI demonstrates definite active inflammation on MRI of SIJ and\u002For spine (ASAS definition of positive MRI and ≥4 SIJ quadrants with BME and\u002For ≥4 vertebral units with BME (in the absence of degenerative disc disease at those discovertebral units with BME)) as determined by central readers.\n7. Presence of chronic back pain in the 3 months prior to screening.\n8. Active disease as defined by a BASDAI value of ≥4 and TBP score of ≥4 (on a 0-10 NRS scale) at screening and baseline.\n9. History of an inadequate response to at least two different NSAIDs over a period of 4 weeks in total at the maximum recommended or tolerated doses, or intolerance\u002Fcontraindication (e.g., allergic reaction, gastrointestinal symptoms or signs, severe arterial hypertension, etc.) for NSAIDs.\n10. For all females of child-bearing potential: must not have a positive serum pregnancy test at the Screening Visit and must have a negative urine pregnancy test at Baseline prior to the first dose of study drug (local practices may require serum pregnancy testing at Baseline). Subjects with a borderline serum pregnancy test at Screening must have absence of clinical suspicion of pregnancy or other pathological causes of borderline results and a serum pregnancy test ≥3 days later to document continued lack of a positive result (unless prohibited by local requirements).\n\n    1. Female subjects of childbearing potential must practice at least 1 protocol-specified method of birth control that is effective from Study Day 1 through at least 30 days after the last dose of study drug (local practices may require 2 methods of birth control). Female subjects of non-childbearing potential do not need to use birth control.\n    2. Females must not be pregnant, breastfeeding, or considering becoming pregnant during the study and for approximately 30 days after the last dose of study drug. Females must commit to one of the following methods of highly effective birth control:\n\n       * Combined (estrogen- and progestogen-containing) hormonal birth control (oral, intravaginal, transdermal, injectable) associated with inhibition of ovulation initiated at least 30 days prior to study baseline.\n       * Progestogen-only hormonal birth control (oral, injectable, implantable) associated with inhibition of ovulation initiated at least 30 days prior to study baseline.\n       * Bilateral tubal occlusion\u002Fligation (can be via hysteroscopy, provided a hysterosalpingogram confirms success of the procedure) (For Japan: only bilateral tubal ligation).\n       * Intrauterine device (IUD).\n       * Intrauterine hormone-releasing system (IUS).\n       * Vasectomized sexual partner (the partner has received medical confirmation of the surgical success of the vasectomy and is the sole sexual partner of the trial subject).\n       * Practice true abstinence (unless not acceptable per local practices), defined as: refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post-ovulation methods\\] and withdrawal are not acceptable).\n11. If required per local practices, females of childbearing potential must commit to using 2 methods of contraception (either 2 highly effective methods or 1 highly effective method combined with 1 effective method). Effective methods of birth control are the following:\n\n    * Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, initiated at least 30 days prior to baseline.\n    * Male or female condom with or without spermicide.\n    * Cap, diaphragm, or sponge with spermicide.\n    * A combination of male condom with a cap, diaphragm, or sponge with spermicide (double barrier method).\n    * In questionable cases of menopausal status, a blood sample with simultaneous levels of follicle stimulating hormone (FSH) above 40 U\u002Fl and estradiol below 30 pg\u002Fml is confirmatory.\n12. Subjects who are regularly taking NSAIDs or analgesics (including mild opioids) as part of their PsA therapy are required to be on a stable dose\u002Fdose regimen for at least 14 days prior to the baseline visit. If entering the study on concomitant tramadol, combination of acetaminophen\u002Fparacetamol and codeine or combination of acetaminophen\u002Fparacetamol and hydrocodone, and\u002For non-opioid analgesics, subject must be on stable dose(s) for at least 14 days prior to the baseline Visit. However, subject must not have used opioid analgesics (except for combination of acetaminophen\u002Fparacetamol and codeine or combination of acetaminophen\u002Fparacetamol and hydrocodone which are allowed) within 14 days prior to the BL Visit.\n13. Subjects taking oral corticosteroids must be on an average daily and stable dose of ≤10mg\u002Fday prednisone or equivalent for at least 14 days prior to the baseline visit.\n14. Subjects taking topical therapies (e.g., topical JAKi, salicylic acid preparations, corticosteroids, retinoids) are allowed, but must be on a stable dose at least 4 weeks prior to the BL visit.\n15. Subjects entering the study on the following concomitant csDMARDs must be on a stable dose as indicated below for at least 28 days prior to the baseline Visit (in case of Leflunomide washout must be either 8 weeks or 4 weeks with a standard cholestyramine wash-out). A combination of up to 2 background csDMARDs is allowed EXCEPT the combination of methotrexate (MTX) and leflunomide.\n\n    * MTX (≤ 25 mg\u002Fweek); or\n    * Sulfasalazine (SSZ) (≤ 3 g\u002Fday); or\n    * Hydroxychloroquine (≤ 400 mg\u002Fday); or\n    * Chloroquine (≤ 250 mg\u002Fday); or\n    * Leflunomide (≤ 20 mg\u002Fday); or\n    * Apremilast (≤ 60 mg\u002Fday)\n16. Subjects must have been treated for ≥ 3 consecutive months prior to the study entry with DMARD therapy (including csDMARD and\u002For bDMARD) and\u002For for ≥4 weeks of NSAID therapy (if csDMARDs are not indicated for their axial disease, in accordance with local product label for PSA, or nr-axSpA\u002FAS for the subset with purely axial disease), but continue to exhibit active SpA, or had to discontinue previous DMARD and\u002For NSAID treatment due to intolerability or toxicity, irrespective of treatment duration .\n\n    1. Subjects recruited in Europe: Subjects must have previously been treated with one or more DMARD (csDMARD as defined in inclusion criterion 15, and\u002For bDMARD) and deemed to be inadequate responders and\u002For intolerant.\n    2. Subjects recruited in the US: Subjects must be TNFi-IR. In this study, an IR to TNFi therapy will be defined as patients who discontinue TNFi due to lack of efficacy based on the investigators' assessment or intolerance (irrespective of treatment duration).\n    3. Subjects recruited in Canada: Subjects must have previously been treated with one or more DMARD (csDMARD as defined in inclusion criterion 15, and\u002For bDMARD) and deemed to be inadequate responders and\u002For intolerant.\n\n       * Up to 20 patients presenting with purely axial disease and current psoriasis (at the time of screening) may be included in the study. These patients may have had a past history of joint involvement, but do not currently require csDMARD therapy. In order to be deemed eligible, these patients must meet both the ASAS Classification Criteria for axSpA and the CASPAR criteria, as well as all other inclusion\u002Fexclusion criteria, including inadequate response to 2 NSAIDs (inclusion criterion #9 - all countries), bioDMARD (Canada), and TNFi (US). The ASAS Classification Criteria for axSpA are provided in Appendix A.\n17. If subjects are currently taking bioDMARD therapy, they may be recruited after an appropriate wash-out period of bioDMARD prior to the screening MRI. Prior exposure to a bioDMARD is allowed for no more than 75 subjects, and prior exposure to a 2nd bioDMARD is allowed for no more than 30 subjects (one bioDMARD must include TNFi for US patients). Washout periods are as follows: 4 weeks for Etanercept, 8 weeks for Infliximab, 10 weeks for Adalimumab, Golimumab, Certolizumab and Ixekizumab, 12 weeks for Ustekinumab, Secukinumab, Guselkumab, and Abatacept, and 20 weeks for Risankizumab. However, subjects should not stop their previous successful biological therapy only to be included in this study. For patients intolerant to bioDMARD and not on such treatment a washout period may not be necessary.\n\nExclusion Criteria:\n\n1. Active infection(s) requiring treatment with parenteral anti-infectives within 30 days, or oral anti-infectives within 14 days prior to the baseline Visit; Chronic recurring infection and\u002For active viral infection that based on the investigator's clinical assessment makes the subject an unsuitable candidate for the study.\n2. Confirmed COVID-19: the baseline visit must be at least 14 days from onset of signs\u002Fsymptoms or positive SARS-CoV-2 test; symptomatic subjects must have recovered, defined as resolution of fever without use of antipyretics and improvement in symptoms;\n3. Suspected COVID-19: subjects with signs\u002Fsymptoms suggestive of COVID-19, known exposure, or high-risk behavior should undergo molecular (e.g., PCR) testing to rule out SARS-CoV-2 infection or must be asymptomatic for 14 days from a potential exposure;\n4. History of recurrent (more than one episode) herpes zoster or disseminated\u002Fmulti-dermatomal (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.\n5. Primary or secondary immunodeficiency.\n6. Current clinical signs and symptoms suggestive for tuberculosis.\n7. Tuberculosis Interferon Gamma Release Assay (IGRA) serum test and abnormal chest x-ray (positive x-ray) suggestive of past or present tuberculosis (both at screening, may be accepted if performed within 180 days prior to screening). If the IGRA test is indeterminate the test should be repeated. If it remains indeterminate the patient should be considered positive. Patients with a positive Tuberculosis IGRA serum test but negative chest x-ray and without clinical symptoms suggestive for tuberculosis may participate in the study after initiation of standard prophylactic anti-tuberculous treatment according to the current local treatment guidelines. At least 2 weeks prophylactic treatment is considered necessary prior to study participation. Patients should not take rifampin concurrently with Upadacitinib.\n8. Chronic infection with hepatitis B virus. At screening HBsAg and anti-HBc will be tested. Patients who are HBsAg positive will be excluded. In case of HBsAg negativity, but anti-HBc positivity, participation in the study is possible if HBV-DNA testing is negative and liver function tests are normal.\n9. Chronic infection with hepatitis C (HCV) (HCV ribonucleic acid (RNA) detectable in any subject with anti-HCV antibody (HCV Ab), or Human Immunodeficiency Virus (HIV) infection confirmed by positive anti-HIV antibody test.\n10. Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 4 weeks following the last dose of study drug.\n11. Subjects with chronic inflammatory articular disease (other than PsO or PsA or SpA), or systemic autoimmune diseases, e.g., systemic lupus erythematosus, Sjögren´s syndrome, RA, unequivocal chronic fatigue syndrome, or unequivocal fibromyalgia. Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease within 4 weeks prior to BL.\n12. Concomitant treatment with strong inductors or inhibitors of cytochrome P450 3A (e.g., Ketoconazole, Fluconazole, Rifampicin, Clarithromycin, St-John´s-wort).\n\n    Strong CYP3A Inhibitors:\n    * Boceprevir\n    * Cobicistat\n    * Clarithromycin\n    * Conivaptan\n    * Grapefruit (fruit or juice)\n    * Indinavir\n    * Itraconazole\n    * Ketoconazole\n    * Lopinavir\u002FRitonavir\n    * Mibefradil\n    * Nefazodone\n    * Nelfinavir\n    * Posaconazole\n    * Ritonavir\n    * Saquinavir\n    * Telaprevir\n    * Telithromycin\n    * Troleandomycin\n    * Voriconazole\n\n    Strong CYP3A Inducers:\n    * Carbamazepine\n    * Phenytoin\n    * Rifampin\n    * Rifapentine\n    * St. John's Wort\n\n    Information regarding potential drug interactions with upadacitinib can be located in the upadacitinib Investigator's Brochure.\n13. Prior treatment with upadacitinib or another JAK-inhibitor or TYK2-inhibitor.\n14. History of hypersensitivity to any component of upadacitinib tablets.\n15. Treatment with intravenous, intramuscular or intraarticular\u002Fperiarticular, or intrarectal steroids within 4 weeks prior to baseline Visit; treatment with oral steroids in a dose of \\>10 mg prednisolone equivalent per day.\n16. Subject must not have been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half-lives (whichever is longer) prior to the first dose of study drug or is currently enrolled in another interventional clinical study.\n17. History of an infected joint prosthesis at any time, with the prosthesis still in situ.\n18. Actual malignancies or history of malignancies with curative treatment within 5 years prior to screening, except successfully treated non-metastatic squamous cell or basal cell carcinoma of the cutis or carcinoma in situ of the cervix.\n19. A subject with any condition possibly affecting oral drug absorption, e.g., gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery such as gastric bypass. Procedures such as gastric banding, that simply divides the stomach into separate chambers, are NOT exclusionary.\n20. Significant trauma or surgery procedure within 4 weeks prior to baseline or any preplanned elective surgery during the study period.\n21. Evidence of other severe uncontrolled gastrointestinal, hepatic (serum albumin \\\u003C25 mg\u002Fl or Child-Pugh-Score \\>10), renal, pulmonary, cardiovascular, nervous or endocrine disorders.\n22. Any history of prior cardiovascular event, including but not limited to cerebrovascular accident, myocardial infarction, coronary stenting, and aorto-coronary bypass surgery.\n23. History of thrombosis and\u002For hematological disorder increasing the propensity to thrombosis.\n24. Any subject who has been vaccinated with live or attenuated vaccines within the 4 weeks prior to the first dose of study medication or is to be vaccinated with these vaccines at any time during treatment or within 4 weeks after the last dose of study drug.\n\n    * Examples of live vaccines include, but are not limited to, the following:\n\n      1. Monovalent live influenza A (H1N1) (intranasal);\n      2. Seasonal trivalent live influenza (intranasal);\n      3. Zostavax (herpes zoster, live attenuated);\n      4. Rotavirus;\n      5. Varicella (chicken pox);\n      6. Measles-mumps-rubella or measles-mumps-rubella-varicella;\n      7. Oral polio vaccine;\n      8. Smallpox;\n      9. Yellow fever;\n      10. Bacille Calmette-Guérin;\n      11. Typhoid (oral).\n    * Administration of inactivated (non-replicating) vaccines is permitted prior to or during the study according to local practice guidelines. Examples of common vaccines that are inactivated, toxoid or biosynthetic include, but are not limited to, injectable influenza vaccine, pneumococcal, Shingrix (zoster vaccine, recombinant, adjuvanted), pertussis (Tdap) vaccines, monkey pox vaccine and SARS-CoV-2 (inactivated, mRNA, RNA). Whenever possible, subjects should not have received a COVID-19 vaccination in the 7 days prior to randomization or plan to receive a COVID-19 vaccination within the first 7 days after initiation of study drug.\n25. Any of the following lab abnormalities detected at screening:\n\n    1. Hemoglobin \\\u003C8 g\u002Fdl;\n    2. Absolute neutrophil count \\\u003C1.0 x 109\u002FL (\\\u003C1000\u002Fmm3)\n    3. Absolute lymphocyte count \\\u003C0.50 x 109\u002FL (\\\u003C750\u002Fmm3)\n    4. Platelet count \\\u003C100 x 109\u002FL (\\\u003C100,000\u002Fmm3).\n26. Patients with contraindications for the MRI including but not limited to claustrophobia, seizure disorders, presence of an implanted electronic device (e.g. heart pacemaker, insulin pump, etc.) or metal implants not known to be MRI safe and metal foreign bodies in the patient's body suspected to be ferromagnetic, tattoos performed with metal-containing paints or tattoos of large skin areas.",{"count":477,"type":21},100,[211],"A Randomized, Placebo-controlled, Multicenter, Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients with Active Psoriatic Arthritis (UP-SPOUT)",[27,481],"Spondyloarthritis, Axial","2026-03-30",{"date":484,"type":37},"2026-04-03",{"date":486,"type":37},"2024-12-03",{"date":488,"type":21},"2028-10",{"name":490,"class":44},"CARE ARTHRITIS LTD.",5,{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":4,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":499,"enrollmentInfo":500,"targetDuration":4,"studyType":22,"phases":502,"briefSummary":503,"conditions":504,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":200},"100615661","phase-2-a-study-of-picankibart-in-patients-with-active-psoriatic-arthritis-100615661","NCT07295509","A Study of Picankibart in Patients With Active Psoriatic Arthritis","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II\u002FIII Clinical Study to Evaluate the Efficacy and Safety of Picankibart in Patients With Active Psoriatic Arthritis","Inclusion Criteria:\n\n1. Age 18-75 years\n2. Diagnosed with PsA for ≥3 months, and meeting Classification Criteria for Psoriatic Arthritis (CASPAR) at screening\n3. Having active PsA: ≥3 tender joints and ≥3 swollen joints at screening and baseline\n4. Having active plaque psoriasis (≥1 lesion ≥2cm) or nail psoriasis, or a documented history of plaque psoriasis\n5. Inadequate response or intolerance to prior NSAIDs or non-biologic DMARDs\n6. Stable doses of protocol permitted background therapy (if any)\n\nExclusion Criteria:\n\n1. Other inflammatory conditions that may affect the evaluation of the study drug\n2. Prior treatment with \\>2 biologic agents\n3. Recent use of prohibited medications (specific washout periods apply)\n4. Non-plaque psoriasis forms or drug-induced psoriasis\n5. Severe, progressive, or uncontrolled renal, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, hematological, rheumatic (excluding PsA), psychiatric, or genitourinary conditions\n6. Significant laboratory abnormalities\n7. Pregnancy or breastfeeding","75 Years",{"count":501,"type":21},222,[78,24],"This is a multicenter, randomized, double-blind, placebo-controlled Phase II\u002FIII clinical trial evaluating the efficacy and safety of picankibart (IBI112) in patients with active psoriatic arthritis (PsA). The study consists of two stages: Phase II dose-finding (n=90) and Phase III confirmatory (n=132). Participants will receive subcutaneous (SC) injections of either picankibart (200mg) or placebo with different dosing schedules, with placebo crossover to active treatment at Week 26. The Phase II portion will identify optimal dosing for Phase III, which will confirm efficacy. The study will evaluate improvements in joint symptoms, physical function, quality of life, and skin manifestations. Primary endpoint is percentage of participants who achieved an American College of Rheumatology (ACR) 20 Response at Week 24.",[27],"2026-03-18",{"date":507,"type":37},"2026-03-20",{"date":509,"type":37},"2025-12-18",{"date":511,"type":21},"2029-12-31",{"name":513,"class":44},"Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.",{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":520,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":522,"enrollmentInfo":523,"targetDuration":4,"studyType":306,"phases":4,"briefSummary":525,"conditions":526,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":200},"100442271","biobank-for-inflammatory-chronic-diseases-and-osteoporosis-100442271","NCT05039216","Biobank for Inflammatory Chronic Diseases and Osteoporosis","Biobank for Inflammatory Chronic Diseases and Osteoporosis of TOULouse","BIOTOUL","Inclusion Criteria:\n\n* Chronic inflammatory rheumatism including RA, SpA or PsA or patients with primary or secondary osteoporosis\n* With National Health Assurance\n* Able to consent to the study\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Not able to give a consent\n* Severe anemia (Hb\\\u003C10g\u002FL)","99 Years",{"count":524,"type":21},2000,"The aim of this study is to constitute a biobank for patients followed in the Rheumatology center of Toulouse University Hospital for a chronic inflammatory rheumatism including rheumatoid arthritis (RA), spondyloarthritis(SpA), and psoriatic arthritis (PsA) or a chronic bone disease including osteoporosis in order to identify biomarkers associated with therapeutic response.",[159,27,527,528],"Spondyloarthritis","Osteoporosis","2026-03-16",{"date":531,"type":37},"2026-03-19",{"date":533,"type":37},"2021-09-13",{"date":535,"type":21},"2031-09-01",{"name":537,"class":199},"University Hospital, Toulouse",{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":544,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":499,"enrollmentInfo":546,"targetDuration":4,"studyType":306,"phases":4,"briefSummary":548,"conditions":549,"keywords":550,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":561},"100574854","an-ex-us-study-to-assess-treatment-persistence-with-risankizumab-in-adult-participants-with-psoriatic-arthritis-100574854","NCT06764693","An Ex-US Study to Assess Treatment Persistence With Risankizumab in Adult Participants With Psoriatic Arthritis","Prospective Multi-country, Real-world, Multi-arm Study of Treatment PErsistence With RISankizumab in Psoriatic Arthritis (PERIS)","PERIS","Inclusion Criteria:\n\n* Participant with a clinical diagnosis of psoriatic arthritis (PsA) with symptom onset at least 6 months prior to the Screening visit and fulfillment of ClASsification for Psoriatic ARthritis (CASPAR) at Baseline visit to confirm that the participant has active disease.\n* Participant must have demonstrated an inadequate response to at least 1 Disease-modifying antirheumatic drug (DMARD) (with max 50% Biologic DMARD-Inadequate Response); alternatively, participant must have demonstrated an intolerance to or contraindication for csDMARDs as determined by the investigator.\n\nExclusion Criteria:\n\n\\- Participants demonstrated an inadequate response to three or more bDMARDs\u002Ftargeted synthetic DMARDs (tsDMARDs).",{"count":547,"type":21},1200,"Psoriatic arthritis (PsA) is a type of arthritis (swelling and stiffness in the joints) that is frequently seen in trial participants who also have the skin condition psoriasis. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. This study aims to describe the long term usage and effectiveness with risankizumab (RZB) relative to other advanced therapeutic options for the management of PsA in daily clinical practice.\n\nRisankizumab is an approved drug for the treatment of psoriatic arthritis. The study will not be conducted in the United States, however it will be conducted in approximately 15 countries and include at least 900 and up to 1200 participants with a 2 to1 ratio of participant allocation between participants receiving risankizumab and participants receiving other advanced therapeutic agents.\n\nThe therapy is prescribed in the usual manner in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population, and indication. All study visits will occur during routine clinical practice and participants will be followed for 24 months.\n\nThere is expected to be no additional burden for participants in this study.",[27],[551],"Risankizumab, Skyrizi","2026-02-12",{"date":554,"type":37},"2026-02-17",{"date":556,"type":37},"2025-01-31",{"date":558,"type":21},"2029-02",{"name":560,"class":44},"AbbVie",132,{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":566,"acronym":4,"eligibilityCriteria":567,"healthyVolunteers":252,"sex":17,"minAge":18,"maxAge":522,"enrollmentInfo":568,"targetDuration":570,"studyType":306,"phases":4,"briefSummary":571,"conditions":572,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":200},"100393366","rheumatology-patient-registry-and-biorepository-100393366","NCT04402086","Rheumatology Patient Registry and Biorepository","Inclusion Criteria for Rheumatology Patients:\n\n* Patients ≥18 years old with a diagnosis of a rheumatic autoimmune disease including, but not limited to: adult onset Still's disease, ankylosing spondylitis, antiphospholipid syndrome, Behcet's disease, dermatomyositis, giant cell arteritis, mixed connective tissue disease, polymyalgia rheumatica, polymyositis, psoriatic arthritis, reactive arthritis, rheumatoid arthritis, sarcoidosis, scleroderma, Sjogren's syndrome, systemic lupus erythematosus, undifferentiated connective tissue disease and vasculitis.\n* Receiving clinical care at Yale Rheumatology clinics\n\nExclusion Criteria for Rheumatology Patients:\n\n* Unable to provide informed consent\n* No patients will be excluded based on gender or ethnicity or pregnancy status.\n* Women who are currently pregnant will need to wait to donate a skin biopsy until after they deliver.\n* Patients allergic to lidocaine or epinephrine or have a history of impaired wound healing will not be able to donate a skin biopsy.\n\nInclusion Criteria for Healthy Volunteers:\n\n* Age ≥ 18 years old\n* No chronic skin conditions\n* No diagnosis of a rheumatic autoimmune disease (e.g., lupus, rheumatoid arthritis)\n* Normal BMI\n\nExclusion Criteria for Healthy Volunteers:\n\n* Unable to provide informed consent.\n* Currently pregnant or nursing unless the study goal is to study pregnant or nursing woman.\n* Allergies to lidocaine or epinephrine (skin biopsies).\n* A history of impaired wound healing (skin biopsies).",{"count":569,"type":21},5000,"10 Years","To facilitate clinical, basic science, and translational research projects involving the study of rheumatic diseases.",[573,574,331,27,335,575,161,576,153,577,578,579,580,581,159,582,451,583,584,585],"Rheumatic Diseases","Adult Onset Still Disease","Antiphospholipid Syndrome","Behcet Disease","Polymyositis","Giant Cell Arteritis","Lyme Disease","Mixed Connective Tissue Disease","Polymyalgia Rheumatica","Sarcoidosis","Scleroderma","Sjogren's Syndrome","Undifferentiated Connective Tissue Diseases","2026-02-11",{"date":588,"type":37},"2026-02-13",{"date":590,"type":37},"2020-08-04",{"date":592,"type":21},"2030-06-01",{"name":594,"class":199},"Yale University",{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":4,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":602,"enrollmentInfo":603,"targetDuration":4,"studyType":22,"phases":605,"briefSummary":606,"conditions":607,"keywords":610,"overallStatus":310,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":620,"locationsCount":200},"100623593","apremilast-and-adalimumab-in-psoriatic-arthritis-patients-100623593","NCT07398651","Apremilast and Adalimumab in Psoriatic Arthritis Patients","Comparative Study Between Apremilast and Adalimumab in Psoriatic Arthritis Patients","Inclusion Criteria:\n\n* This study will include 60 adult Psoriatic arthritis patients \\>18 years old, fulfilling the (CASPAR) classification criteria of Psoriatic arthritis and have an inadequate response to methotrexate therapy for at least 3 months.\n\n  * Psoriatic arthritis patients with peripheral musculoskeletal domains (peripheral arthritis, dactylitis and enthesitis) as well as skin and nail domains\n\nExclusion Criteria:\n\n* Patients who received previous biologic agents or Janus kinase inhibitors.\n* Patients with axial and ocular involvement.\n* Current or recent serious infection including tuberculosis or hepatitis B\u002FC .\n* Current or past history of malignancy (within five year).\n* Pregnant or breastfeeding women or women planning pregnancy during the study period .\n* Severe uncontrolled comorbidities such as heart failure, severe liver disease, or chronic kidney disease (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m²) .","70 Years",{"count":604,"type":21},60,[184],"The aim of this work is to compare the efficacy of Apremilast combined with Methotrexate versus Adalimumab combined with Methotrexate",[27,608,609],"Ultrasound Assessment","TNF",[611,612,613],"Psoriatic Arthritis Patients:","Apremilast","Adalimumab","2026-02-09",{"date":616,"type":37},"2026-02-10",{"date":618,"type":21},"2026-12-30",{"date":618,"type":21},{"name":621,"class":199},"Tanta University",{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":4,"eligibilityCriteria":628,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":602,"enrollmentInfo":629,"targetDuration":4,"studyType":22,"phases":631,"briefSummary":632,"conditions":633,"keywords":4,"overallStatus":310,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":639,"locationsCount":641},"100624161","phase-2-a-phase-ii-clinical-trial-to-evaluate-the-efficacy-and-safety-of-tqh3906-capsules-in-the-treatment-of-active-psoriatic-arthritis-100624161","NCT07406035","A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis","A Randomized, Placebo- and Active Drug-Controlled, Double-Blind, Multicenter, Parallel-Group Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis","Inclusion Criteria:\n\n* Sign a written Informed Consent Form, which must meet the following requirements\n\n  * Be willing to participate in the study and able to sign the informed consent form;\n  * Be willing and able to complete all study-specific procedures and visits;\n* PsA trial participant disease characteristics\n\n  * Aged 18 to 70 years（inclusive）;\n  * BMI ≥ 18 kg\u002Fm² at screening; diagnosed with PsA for at least 3 months prior to screening, and meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) at screening;\n  * Active arthritis at screening and at baseline (Day 1);\n  * Has failed or was intolerant to at least one prior therapy;\n  * If receiving a conventional synthetic Disease-Modifying Antirheumatic Drug (csDMARD), trial participants must be on only one DMARD, which must have been administered for at least 3 months prior to screening, with a stable dose for at least 28 days prior to the first dose;\n  * If using NSAIDs, the dose must have been stable for at least 14 days before the first dose;\n  * If using oral corticosteroids, the dose must have been stable for at least 14 days before the first dose;\n  * Topical treatments for plaque psoriasis must have remained stable for at least 14 days before the first dose;\n* Women of childbearing potential must agree to use effective contraception during the study and for 6 months after the end of the study; men must agree to use effective contraception during the study and for 6 months after the end of the study\n\nExclusion Criteria:\n\n* Presence of conditions other than PsA:\n\n  * Presence of non-plaque psoriasis (i.e., guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis) at screening or first dose;\n  * Presence of any other autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus, etc.;\n  * Presence of active (i.e., currently symptomatic) fibromyalgia;\n* Other Medical Conditions and Medical History:\n\n  * Trial participants who are pregnant or breastfeeding;\n  * Evidence of a serious illness\u002Fcondition or unstable clinical condition, or localized active infection\u002Finfectious disease;\n  * Any major surgery performed within 30 days prior to the first dose of study treatment, or any planned surgery during the study;\n  * Cancer or a history of cancer or lymphoproliferative disease within the past 5 years;\n  * New York Heart Association (NYHA) Class III or IV congestive heart failure, or any recent episode of heart failure resulting in NYHA Class III\u002FIV symptoms; or a history of clinically significant ventricular arrhythmia or arrhythmia requiring continuous antiarrhythmic drug therapy;\n  * Uncontrolled hypertension at screening or randomization;\n  * History of thrombotic disease within 24 weeks prior to screening; viii. History of acute coronary syndrome and\u002For any major cerebrovascular disease within 24 weeks prior to screening;\n  * Current or recent (within 3 months prior to randomization) gastrointestinal disease that may affect absorption of study treatment, including gastrointestinal surgery;\n  * Severe blood loss (\\> 500 mL) or blood transfusion within 4 weeks prior to randomization;\n  * Inability to take oral medication;\n  * Inability to undergo venipuncture and\u002For tolerate venous access;\n  * History of substance abuse with inability to abstain or presence of a psychiatric disorder;\n  * Any other medical, psychiatric, and\u002For social reason as determined by medical judgment;\n* Prior and concomitant medications: If the trial participant has a history of biologic use, the exclusion criteria specified in the protocol will apply;\n* Infection-related:\n\n  * Active tuberculosis identified by chest radiography within 6 months prior to screening; trial participants with a negative chest radiography within 3 months prior to screening are eligible if they meet the protocol requirements;\n  * Hepatitis C, hepatitis B, or human immunodeficiency virus (HIV) infection; or syphilis infection requiring treatment;\n* Abnormal physical examination or laboratory findings;\n* Other:\n\n  * History of any major drug allergy; known allergy to any excipient of the investigational product;\n  * Inability to comply with the trial protocol;\n  * History of substance abuse with inability to abstain or presence of a psychiatric disorder;\n  * Participation in another clinical trial and use of another investigational drug (other than for psoriatic arthritis) within 4 weeks prior to the first dose, based on the date of discontinuation from the previous trial;\n  * Planned or previous allogeneic bone marrow transplantation or solid organ transplantation;\n  * Any condition that, in the investigator's judgment, poses a serious risk to the safety of the trial participant or affects the participant's ability to complete the study.",{"count":630,"type":21},156,[78],"This study is a marketing-oriented clinical trial of TQH3906 Capsules. A total of 156 participants are planned to be enrolled, aiming to evaluate the dose-effect relationship of TQH3906 versus placebo in the treatment of active Psoriatic Arthritis (PsA) at Week 12, with the proportion of participants achieving an American College of Rheumatology 20% (ACR20) Improvement Criteria (ACR20) response at Week 12 as the primary endpoint.",[27],"2026-02-05",{"date":552,"type":37},{"date":637,"type":21},"2026-04",{"date":220,"type":21},{"name":640,"class":44},"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.",43,{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":646,"acronym":647,"eligibilityCriteria":648,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":499,"enrollmentInfo":649,"targetDuration":4,"studyType":22,"phases":650,"briefSummary":651,"conditions":652,"keywords":4,"overallStatus":310,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":654,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":200},"100623996","rewiring-the-brain-immune-axis-for-chronic-pain-using-transcranial-magnetic-stimulation-in-psoriatic-arthritis-100623996","NCT07403890","Rewiring the Brain-Immune Axis for Chronic Pain Using Transcranial Magnetic Stimulation in Psoriatic Arthritis","REACT","Inclusion Criteria:\n\n* Adults ≥ 18 years ≤ 75 years\n* Diagnosis of PsA according to CASPAR (Classification Criteria for Psoriatic Arthritis).\n* Low disease activity (no more than one joint with clinically active swelling) or remission\n* Chronic pain for at least 3 months and VAS (Visual Analogue Scale) pain ≥30 mm\n* Stable treatment ≥3 months prior to entering the study\n* Able and willing to maintain medication for the duration study\n* Able to undergo MRI and TMS procedures\n\nExclusion Criteria:\n\n* Inability to provide written informed consent.\n* Severe physical impairment (e.g. blindness, deafness, paraplegia) Pregnant, planning pregnancy or breast feeding.\n* Severe claustrophobia precluding MRI.\n* Contraindications to MRI (e.g. metal implants\u002F pacemaker).\n* Contraindications to TMS (e.g. history of seizures).\n* Serious infection including sepsis, tuberculosis and opportunistic infections such as invasive fungal infections.\n* Major confounding neurological disease including Multiple\n* Sclerosis, Stroke, Traumatic Brain Injury, Parkinson's Disease, Alzheimer's Disease",{"count":283,"type":21},[184],"Despite advances in immunomodulatory therapies, many Psoriatic arthritis (PsA) patients experience persistent pain unrelated to clinical active joint inflammation. Recent evidence suggests the Inferior Parietal Lobule (IPL) serves as a neuroimmune hub linking central neural activity with peripheral immune dysregulation. In a prior feasibility study, a single L-IPL-targeted TMS session reduced pain and altered immune signalling in inflammatory arthritis by reducing STAT3 phosphorylation in circulating monocytes. This study builds on those findings by evaluating whether rTMS over 4 weeks can induce sustained immune reprogramming while providing meaningful pain relief.",[27],"2026-02-04",{"date":586,"type":37},{"date":656,"type":21},"2026-03-01",{"date":658,"type":21},"2028-03-28",{"name":660,"class":199},"NHS Greater Glasgow and Clyde",{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":666,"acronym":667,"eligibilityCriteria":668,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":669,"targetDuration":4,"studyType":22,"phases":671,"briefSummary":672,"conditions":673,"keywords":4,"overallStatus":310,"whyStopped":4,"lastUpdateSubmitDate":674,"lastUpdatePostDateStruct":675,"startDateStruct":677,"completionDateStruct":679,"leadSponsor":681,"locationsCount":684},"100620059","combined-high-intensity-aerobic-training-and-resistance-training-in-psoriatic-arthritis-100620059","NCT07352696","Combined High-Intensity Aerobic Training and Resistance Training in Psoriatic Arthritis","Effects of Combined High-Intensity Aerobic Training and Resistance Training on Cardiovascular and Metabolic Health in Psoriatic Arthritis","PsA-HIIT","Inclusion Criteria:\n\n* Psoriatic arthritis disease according to the CASPAR (Classification Criteria for Psoriatic Arthritis) criteria\n* Age range 18-65 years\n* Stable medication on anti- rheumatic drugs for \\>3 months prior to inclusion and throughout the first 3 months of the study\n\nExclusion Criteria:\n\n* Cardiovascular disease\n* Severe hypertension\n* Diabetes type I\n* Chronic obstructive pulmonary disease or other severe pulmonary diseases\n* Arthroplasty of large joints, lower extremities\n* Severe functional impairment precluding participation in high-intensity aerobic exercise\n* Inability to perform a cardiopulmonary exercise testing (CPET)\n* Pregnancy\n* BMI ≥35 kg\u002Fm²\n* Ongoing or planned initiation (within 3 months) of structured weight reduction therapy, pharmacological obesity treatment, or bariatric bypass surgery\n* Already participating in regular exercise at high intensity (BORG ≥15) for \\>1 hour\u002F week during the past 6 months\n* Inability to understand and read Swedish",{"count":670,"type":21},88,[184],"The goal of this randomised controlled trial is to evaluate the effects of a 12-week intervention comprising high-intensity interval aerobic training and strength training on cardiovascular function, metabolic health profile and inflammation in patients with Psoriatic arthritis. A secondary goal is to assess the intervention´s impact on physical fitness, pain, fatigue, and health-related quality of life, and to explore long-term maintenance of exercise following completion of the intervention. We hypothesize that 12 weeks of combined high-intensity interval aerobic training and strength training will improve cardiometabolic health, inflammation, and enhance physical fitness, fatigue, pain and quality of life in Psoriatic arthritis.",[27],"2026-01-19",{"date":676,"type":37},"2026-01-22",{"date":678,"type":21},"2026-02-02",{"date":680,"type":21},"2028-12",{"name":682,"class":683},"Vastra Gotaland Region","OTHER_GOV",2]